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Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus

Primary Purpose

Esophageal Cancer

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

cisplatin

fluorouracil

conventional surgery

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage II esophageal cancer, stage III esophageal cancer, squamous cell carcinoma of the esophagus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed esophageal squamous cell cancer that is stage T2-3 Nx M0 PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5 years except: Basal cell skin carcinoma Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

Sites / Locations

University of Padua

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002897

First Posted

November 1, 1999

Last Updated

September 19, 2013

Sponsor

European Institute of Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00002897

Brief Title

Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus

Official Title

RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Completed

Study Start Date

July 1992 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

European Institute of Oncology

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether chemotherapy before surgery is more effective than surgery alone in treating cancer of the esophagus. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus.

Detailed Description

OBJECTIVES: I. Compare resectability and survival in patients with stage II/III esophageal cancer treated with neoadjuvant cisplatin/fluorouracil vs. surgery alone. OUTLINE: This is a randomized study. Patients are randomized to one of two groups. The first group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by esophagectomy and regional lymphadenectomy. The second group undergoes esophagectomy and regional lymphadenectomy alone. All patients are followed for survival. PROJECTED ACCRUAL: A total of 240 patients will be entered over 4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

stage II esophageal cancer, stage III esophageal cancer, squamous cell carcinoma of the esophagus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ermanno Ancona, MD

Organizational Affiliation

Azienda Ospedaliera di Padova

Official's Role

Study Chair

Facility Information:

Facility Name

University of Padua

City

Padua

ZIP/Postal Code

35128

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

11391598

Citation

Ancona E, Ruol A, Santi S, Merigliano S, Sileni VC, Koussis H, Zaninotto G, Bonavina L, Peracchia A. Only pathologic complete response to neoadjuvant chemotherapy improves significantly the long term survival of patients with resectable esophageal squamous cell carcinoma: final report of a randomized, controlled trial of preoperative chemotherapy versus surgery alone. Cancer. 2001 Jun 1;91(11):2165-74.

Results Reference

result

Citation

Ancona E, Ruol A, Santi S, et al.: Major response to neoadjuvant chemotherapy leads to improved long-term survival in potentially resectable (T2-3, any N, M0) esophageal squamous cell carcinoma. Final report of a randomized trial of neoadjuvant chemotherapy versus surgery alone. [Abstract] Proceedings of the European Surgical Association 7th annual meeting, Amsterdam, April 14-15, 2000.

Results Reference

result

Learn more about this trial

Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus

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